Brand Name | AFFINITI 50 |
Type of Device | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASON |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
|
bothell WA 98021 |
|
Manufacturer Contact |
thuy
nguyen
|
22100 bothell everett highway |
bothell, WA 98021
|
|
MDR Report Key | 16397918 |
MDR Text Key | 309862294 |
Report Number | 3019216-2023-00018 |
Device Sequence Number | 1 |
Product Code |
IYN
|
UDI-Device Identifier | 00884838056244 |
UDI-Public | 00884838056244 |
Combination Product (y/n) | N |
Reporter Country Code | TH |
PMA/PMN Number | K132304 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
02/17/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 989605410251 |
Device Catalogue Number | 795208 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/17/2023 |
Date Device Manufactured | 05/03/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|